NCT00820859

Brief Summary

The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 3, 2009

Status Verified

July 1, 2009

Enrollment Period

5 years

First QC Date

January 8, 2009

Last Update Submit

July 1, 2009

Conditions

DementiaBehavior Problems

Keywords

Cognition disordernursing home residentsagitationbehavior disorder

Outcome Measures

Primary Outcomes (1)

  • Agitation Behavior Mapping Instrument (ABMI)

    10 days of intervention vs. 10 days of baseline

Secondary Outcomes (1)

  • affect/mood measured by Lawton's behavior stream assessment

    10 days of intervention vs. 10 days of baseline

Study Arms (2)

1

EXPERIMENTAL
Behavioral: TREA (Treatment Routes for Exploring Agitation)

2

ACTIVE COMPARATOR
Behavioral: Placebo Control Group

Interventions

TREA (Treatment Routes for Exploring Agitation)BEHAVIORAL

Individualized non-pharmacological treatment plan for agitation

1
Placebo Control GroupBEHAVIORAL

A presentation on the treatment of behavior problems in dementia given to the staff caregivers of the comparison group

2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 or older
  • Diagnosis of dementia derived from the resident's medical chart at the facility or from an attending physician, as based on DSM-IV criteria and the Report of the NINCDS-ADRDA
  • Resident of the facility for at least three weeks so that nursing staff members know the resident well enough to accurately assess him or her
  • Identified by nursing staff to exhibit either verbal agitation or physical non-aggressive agitation at least several times a day

You may not qualify if:

  • Lifelong diagnosis of schizophrenia
  • Bipolar disorder diagnosed prior to onset of dementia
  • Diagnosis of premorbid mental retardation
  • Judged by direct-care nursing staff to have a life expectancy of less than 3 months
  • Expected to leave the nursing home (either to enter the hospital or to go home) within the next 4 months
  • Agitation manifested less than 6 times a day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute on Aging

Rockville, Maryland, 20814, United States

RECRUITING

Related Publications (4)

  • Cohen-Mansfield J. Agitated behavior in persons with dementia: the relationship between type of behavior, its frequency, and its disruptiveness. J Psychiatr Res. 2008 Nov;43(1):64-9. doi: 10.1016/j.jpsychires.2008.02.003. Epub 2008 Apr 3.

    PMID: 18394647BACKGROUND

  • Cohen-Mansfield J, Libin A, Marx MS. Nonpharmacological treatment of agitation: a controlled trial of systematic individualized intervention. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):908-16. doi: 10.1093/gerona/62.8.908.

    PMID: 17702884BACKGROUND

  • Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.

    PMID: 2715584BACKGROUND

  • Cohen-Mansfield J, Thein K, Marx MS, Dakheel-Ali M, Freedman L. Efficacy of nonpharmacologic interventions for agitation in advanced dementia: a randomized, placebo-controlled trial. J Clin Psychiatry. 2012 Sep;73(9):1255-61. doi: 10.4088/JCP.12m07918.

    PMID: 23059151DERIVED

Related Links

MeSH Terms

Conditions

DementiaMental DisordersCognition DisordersPsychomotor Agitation

Interventions

Trehalase

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

DisaccharidasesGlycoside HydrolasesHydrolasesEnzymesEnzymes and Coenzymes

Study Officials

  • Jiska Cohen-Mansfield, PhD

    Research Institute on Aging

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiska Cohen-Mansfield, PhD

CONTACT

301-770-8453cohen-mansfield@hebrew-home.org

Marcia S. Marx, PhD

CONTACT

301-770-8451marx@hebrew-home.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 12, 2009

Study Start

June 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 3, 2009

Record last verified: 2009-07

Locations

US(1)